A nicotine mouth spray provided a safe and effective smoking cessation option for smokers motivated to quit, even in naturalistic settings and without behavioral support, according to findings recently published in Nicotine & Tobacco Research.

“Aside from the nicotine nasal spray that has limited appeal due to initial local irritation, existing [nicotine replacement therapy] formats are limited by relatively slow systemic absorption of nicotine,” Mitchell Nides, PhD, founder and president of Los Angeles Clinical Trials, and colleagues wrote.

“Because craving for cigarettes and exposure to cues associated with smoking have been suggested to play a significant role in relapsing after attempts to quit smoking, it has been suggested that the effectiveness of [nicotine replacement therapy] could be increased if the regimen provided faster and more effective relief from situational cravings,” they added.

Researchers randomly assigned 1,198 patients to receive a 1 mg spray of nicotine mouth spray as needed 1 day after their baseline carbon monoxide levels were recorded or placebo for 26 weeks.

A nicotine mouth spray provided a safe and effective smoking cessation option for smokers motivated to quit, even in naturalistic settings and without behavioral support, according to findings recently published in Nicotine & Tobacco Research.

Source:Shutterstock

Nides and colleagues found the percentage of patients with carbon monoxide-verified continuous abstinence from week 2 to week 6 was greater in the nicotine mouth spray group vs. the placebo group (5% vs. 2.5%, P = .021). Those receiving the nicotine mouth spray had statistically significant treatment effects throughout the 26-week study period. The nicotine mouth spray was well-tolerated, there were no clinically meaningful differences in recipients’ vital signs, and adverse events — hiccups, nausea and headache — were similar between the groups.

“To simulate an [over-the-counter] environment, there were few inclusion/exclusion criteria. Subjects with a contraindication for use, such as diabetes and uncontrolled high blood pressure could be enrolled with the consent of the subject’s physician, as could subjects taking medications for depression or anxiety, or opioids for pain. Often, these subjects are excluded from controlled trials. Also, although motivation to quit with the help of a new nicotine replacement therapy was an entry criterion, a cutoff for level of motivation was not established, which could have led to lower quit rates,” Nides and colleagues wrote.

“Unlike a typical controlled clinical study design, where various forms of intensive interventions and measures are taken to create a tightly controlled environment, the study provided no behavioral counseling or support by the study staff,” they added.

A nicotine mouth spray provided a safe and effective smoking cessation option for smokers motivated to quit, even in naturalistic settings and without behavioral support, according to findings recently published in Nicotine & Tobacco Research.

“Aside from the nicotine nasal spray that has limited appeal due to initial local irritation, existing [nicotine replacement therapy] formats are limited by relatively slow systemic absorption of nicotine,” Mitchell Nides, PhD, founder and president of Los Angeles Clinical Trials, and colleagues wrote.

“Because craving for cigarettes and exposure to cues associated with smoking have been suggested to play a significant role in relapsing after attempts to quit smoking, it has been suggested that the effectiveness of [nicotine replacement therapy] could be increased if the regimen provided faster and more effective relief from situational cravings,” they added.

Researchers randomly assigned 1,198 patients to receive a 1 mg spray of nicotine mouth spray as needed 1 day after their baseline carbon monoxide levels were recorded or placebo for 26 weeks.

A nicotine mouth spray provided a safe and effective smoking cessation option for smokers motivated to quit, even in naturalistic settings and without behavioral support, according to findings recently published in Nicotine & Tobacco Research.

Source:Shutterstock

Nides and colleagues found the percentage of patients with carbon monoxide-verified continuous abstinence from week 2 to week 6 was greater in the nicotine mouth spray group vs. the placebo group (5% vs. 2.5%, P = .021). Those receiving the nicotine mouth spray had statistically significant treatment effects throughout the 26-week study period. The nicotine mouth spray was well-tolerated, there were no clinically meaningful differences in recipients’ vital signs, and adverse events — hiccups, nausea and headache — were similar between the groups.

“To simulate an [over-the-counter] environment, there were few inclusion/exclusion criteria. Subjects with a contraindication for use, such as diabetes and uncontrolled high blood pressure could be enrolled with the consent of the subject’s physician, as could subjects taking medications for depression or anxiety, or opioids for pain. Often, these subjects are excluded from controlled trials. Also, although motivation to quit with the help of a new nicotine replacement therapy was an entry criterion, a cutoff for level of motivation was not established, which could have led to lower quit rates,” Nides and colleagues wrote.

“Unlike a typical controlled clinical study design, where various forms of intensive interventions and measures are taken to create a tightly controlled environment, the study provided no behavioral counseling or support by the study staff,” they added.

This drug is another addition to the smoking cessation armamentarium, but it is not the ultimate solution. Only 5% of participants in Nides and colleagues’ study were able to quit smoking with the nicotine mouth spray without behavioral counseling. That is a very low success rate.

While 5% was better than placebo, the greater take-home message here is that the benefit of using short-acting agents to quit smoking is maximized when behavioral counseling is utilized in conjunction with the short-acting agent and that higher smoking cessation rates are likely to be achieved with long-acting nicotine replacement or other pharmaceutical agents.

I believe the manufacturers of this spray intend to make it available over-the-counter in the U.S. if the FDA will approve them doing so. But I don’t think that is the best way to proceed, unless the manufacturers also stress the importance of behavioral counseling. When this same drug was tested in Europe with behavioral counseling, quit rates were closer to 25%.

Disclosures: Hill serves as a speaker for Pfizer, the manufacturer of Chantix (varenicline).

Perspective

The findings by Nides, et al, are not that surprising. The study was trying to approximate the environment in which smokers might want to use the nicotine mouth spray, which is different from the conditions set by clinical trials where there is more tight control of eligibility requirements (such as enrolling people who are planning to quit in the next 30 days). So, the lower quit rates of both the intervention and control groups compared to those found in clinical trials is not surprising. Nevertheless, they still found a higher abstinence rate among people who used the mouth spray compared to people who use the placebo. This suggests that the spray may have a place in the armamentarium of nicotine replacement products that smokers should have available to them.

These researchers simply wanted to see if this product might facilitate quitting by the simple act of using it, and under conditions that many smokers are likely to use it (eg, without behavioral counseling). So, the researchers are not advocating not using behavioral counseling. In fact, their earlier research tested its effectiveness with counseling. So, the study doesn’t change or advocate changing the recommendation that behavioral support should be included in helping smokers achieve abstinence. Health care providers should continue to inform smokers of the many available options for getting behavioral support for cessation, whether by recommending the 1-800-QUIT-NOW telephone counseling quitline, cessation support groups (eg, Nicotine Anonymous), or other resources available through cancer.org, becomeanex.org, and smokefree.gov.

Physicians should continue to emphasize the importance of their patients quitting smoking because of the many detrimental effects smoking has on overall health. If patients do not like any of the currently available nicotine replacement products, physicians might inform them that current research is evaluating the benefit of a spray that may deliver nicotine more quickly than currently FDA-approved nicotine replacement therapies.

At the moment, though, we don’t know how this new spray compares to these other currently available nicotine replacement therapy products or other non-nicotine medications in helping smokers quit, and until that happens physicians should probably hold off on recommending the product (only because the necessary approvals don’t appear to have yet been obtained, even though the product looks very promising). Do not forget that there are other very effective non-nicotine medications that physicians can recommend, such as Chantix (varenicline, Pfizer) which appears to be the most effective cessation medication available.